The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)

ICR 202209-0920-005

OMB: 0920-1357

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2022-09-13
Supplementary Document
2022-09-13
Supplementary Document
2022-09-09
Supplementary Document
2022-09-09
Supporting Statement B
2021-06-17
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supporting Statement A
2022-09-13
ICR Details
0920-1357 202209-0920-005
Received in OIRA 202103-0920-010
HHS/CDC 0920-1357-22IR
The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
No material or nonsubstantive change to a currently approved collection   No
Regular 09/13/2022
  Requested Previously Approved
12/31/2024 12/31/2024
4,898 4,898
1,067 1,067
20,848 20,848

GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. These data will describe the real-world performance and clinical effects of HIV RNA POC NAT testing. CDC will not receive any personally-identifiable information. This Non-Substantive Change Request is submitted to modify the incentives provided to study groups and to improve study implementation logistics. The original plan offered varying incentives by study group which presents operational challenges. The change provides a consistent incentive plan across the primary study groups and also modifies language in consent forms. There is no change to the approved burden hours.

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  85 FR 83087 12/21/2020
86 FR 33294 06/24/2021
Yes

12
IC Title Form No. Form Name
Acceptability/Feasibility Assessment Among Clinical and Community Providers n/a Participant Focus Group / Interview Guide
Baseline Data Collection
Monthly Study Report Form n/a Monthly Study Report Form
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form n/a Release of Information Form
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey 0920-1357, n/a Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in POC NAT Acceptability Survey n/a NAT Acceptability Survey
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form n/a Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey 0920-1357, n/a Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form n/a Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey 0920-1357, n/a Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form n/a Release of Information Form
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form 0920-1357, n/a Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 4,898 4,898 0 0 0 0
Annual Time Burden (Hours) 1,067 1,067 0 0 0 0
Annual Cost Burden (Dollars) 20,848 20,848 0 0 0 0
No
No

$1,346,479
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Jeffrey Zirger 404 639-7118 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
09/13/2022


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